Cybin Inc. (NYSE American: CYBN) (NEO: CYBN) has achieved a significant milestone in mental health treatment with the UK Medicines and Healthcare products Regulatory Agency (MHRA) approving the initiation of its second Phase 3 trial for CYB003, a deuterated psilocin analog aimed at treating Major Depressive Disorder (MDD). This approval marks a pivotal step in the company's PARADIGM program, which seeks to address the urgent need for innovative treatments in the neuropsychiatry field.
The EMBRACE trial, as it is named, will involve 330 patients suffering from moderate to severe MDD across 60 global sites. Participants will be administered either 16 mg or 8 mg of CYB003 or a placebo, with the primary goal of measuring changes in the Montgomery-Åsberg Depression Rating Scale (MADRAS) score at six weeks. This trial builds on the foundation laid by CYB003's previous recognition, including Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).
Doug Drysdale, CEO of Cybin, emphasized the significance of this development, pointing to the broader acceptance and regulatory support for psychedelic-based treatments. The reference to esketamine's $1.7 billion annual run rate underscores the potential market and societal impact of such therapies. With mental health conditions on the rise globally, the success of CYB003 could herald a new era in treatment options, offering hope to millions affected by MDD.
For more information on Cybin's groundbreaking work, visit https://ibn.fm/aWVCz.
